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A Quality Improvement Project to Investigate Individual Provider Variation in Opioid Prescribing From the Emergency Department

23 de junio de 2017 actualizado por: Sean Michael, University of Massachusetts, Worcester
This is a study of emergency physicians' prescribing patterns related to opioid (narcotic) medications. We are trying to determine whether giving providers access to their own prescribing data influences their prescribing patterns.

Descripción general del estudio

Descripción detallada

Opioid misuse is a known public safety threat and public health problem, both nationwide and in the Commonwealth of Massachusetts. As a part of these efforts, Emergency Department (ED) outpatient prescriptions have been identified as a potential area for improvement. The Massachusetts Hospital Association (MHA), in conjunction with other stakeholders, developed a set of recommendations to address opioid management and prescribing within the ED setting.

This study is timed to coincide with the rollout by UMassMemorial Health Care of a system-wide opioid prescribing practice guideline/policy which mirrors the Massachusetts Hospital Association's guideline. This rollout provides a unique opportunity for a natural experiment related to provider prescribing practices.

This is a quality improvement project with two primary objectives:

  • Improve understanding of physician practice patterns related to emergency department (ED) opioid prescribing
  • Evaluate the effectiveness of providing individual clinician profile data in influencing behavior change among ED providers, as it relates to their opioid prescribing patterns

There are two corresponding specific aims:

  • Quantitatively describe the current state of opioid prescribing by ED clinicians at four UMass Memorial EDs (using prescriptions generated within the ED electronic health information system between February 2014 and the study implementation date). Descriptive statistics being considered for feasibility of study include:
  • Number of opioid prescriptions per hundred patients seen
  • Percentage of total prescriptions written that are opioids
  • Mean or median quantity of pills dispensed per opioid prescription
  • Number of prescriptions for long-acting opioid formulations
  • Evaluate the effect on prescribing practices of providing individual clinicians with their profile data to illustrate their personal opioid prescribing patterns, relative to the de-identified distribution for all other clinicians in the ED group

This project is timed to coincide with the separately planned implementation of a system-wide opioid prescribing guideline. The guideline implementation is an independent event, but we feel that it presents a unique opportunity for a simultaneous experimental intervention to assess whether providing clinicians with their individual data alters their prescribing practices beyond any effect achieved simply by being subject to the new guideline. Data collected from the electronic medical record and clinician self-reported data about their perceptions of their prescribing practices will be used to evaluate both the effect of the guideline implementation (i.e. comparison of prescribing patterns for all clinicians before and after guideline implementation) and the combined effect of guideline implementation plus individual profile intervention (i.e. comparisons across intervention versus control groups).

Tipo de estudio

Intervencionista

Inscripción (Actual)

109

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Massachusetts
      • Clinton, Massachusetts, Estados Unidos
        • UMass Clinton Hospital
      • Marlborough, Massachusetts, Estados Unidos
        • UMass Memorial Marlborough Hospital
      • Worcester, Massachusetts, Estados Unidos
        • UMASS Memorial Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Provider who practices Emergency Medicine in one or more of four UMass-affiliated EDs (UMassMemorial Medical Center, Marlborough Hospital, and Clinton Hospital), including attending physicians, resident physicians, and advanced practice providers (PAs and NPs).
  • Have placed at least one electronic prescription for a medication of interest (namely opioids) in the PulseCheck electronic medical record system during the 12 months prior to the implementation of the opioid guidelines
  • Be actively practicing in a UMass-affiliated ED at time of implementation of the guidelines

Exclusion Criteria:

  • None

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control
Providers who are subject only to the routine implementation of clinical practice guidelines without additional experimental intervention
Experimental: Intervention
Providers who are subject to routine clinical practice guideline implementation AND receive provider's own individual prescribing data profile intervention ("Individual prescribing data profile and self-assessment")
Prior to receiving his or her individual data profile, each provider in the intervention group will be asked to identify his or her self-assessment of his or her own opioid prescribing practices. Immediately after providing self-perception data, providers will be provided with their true profile data with a visual display of where they fall within the distribution of their peers. All peer data are de-identified.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change in number of opioid prescriptions per hundred patients seen
Periodo de tiempo: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Change in percentage of total prescriptions written that are opioids
Periodo de tiempo: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
Change in median quantity of pills dispensed per opioid prescription
Periodo de tiempo: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
Change in number of prescriptions for long-acting opioid formulations
Periodo de tiempo: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Self-assessment of decile for number of opioid prescriptions per hundred patients seen
Periodo de tiempo: Once, at time of enrollment
The provider's self-assessment of their decile of number of opioid prescriptions per hundred patients seen, compared to their peers
Once, at time of enrollment
Self-assessment of decile for percentage of total prescriptions written that are opioids
Periodo de tiempo: Once, at time of enrollment
The provider's self-assessment of their decile of their percentage of total prescriptions written that are opioids, compared to their peers
Once, at time of enrollment
Self-assessment of decile for median quantity of pills dispensed per opioid prescription
Periodo de tiempo: Once, at time of enrollment
The provider's self-assessment of their decile of their median quantity of pills dispensed per opioid prescription, compared to their peers
Once, at time of enrollment
Self-assessment of decile for number of prescriptions for long-acting opioid formulations
Periodo de tiempo: Once, at time of enrollment
The provider's self-assessment of their decile of their number of prescriptions for long-acting opioid formulations, compared to their peers
Once, at time of enrollment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Sean Michael, MD, UMass Memorial Health Care

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de febrero de 2016

Finalización primaria (Actual)

1 de marzo de 2017

Finalización del estudio (Actual)

1 de marzo de 2017

Fechas de registro del estudio

Enviado por primera vez

20 de enero de 2016

Primero enviado que cumplió con los criterios de control de calidad

22 de enero de 2016

Publicado por primera vez (Estimar)

27 de enero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de junio de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

23 de junio de 2017

Última verificación

1 de junio de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • H00009241

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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